Avalign

Primary DI
00190776264499
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM80-1544
Device description
Corkscrew T-Handle,
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWICORKSCREW

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWICorkscrewOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776264499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776264499001907762644991907762644990190776264499

GMDN Terms#

Term, Definition table
TermDefinition
Myoma screw, reusableA hand-held manual surgical instrument designed to engage, stabilize, and manipulate a myoma (i.e., a uterine fibroid) and other gynaecological tissues during their surgical removal. It is typically a one-piece instrument designed as a corkscrew having a pointed helicoidal stainless steel screw at the distal end, with a long slender shaft and a handle at the proximal end; it may be inserted through another device (e.g., laparoscope, hysteroscope, trocar) or be used during open surgery. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776439842Millenium85-780939172026-10-29
00190776437176Millennium1-212EB2026-10-28
00190776437183Millennium1-268EB2026-10-28
00190776437190Millennium1-269EB2026-10-28
00190776437206Millennium1-270-11EB2026-10-28
00190776437213Millennium1-293EB2026-10-28
00190776437220Millennium1-244EB2026-10-28
00190776439811Millenium85-140190932026-10-28
00190776439828Millenium85-710188352026-10-28
00190776439835Millenium85-640033142026-10-28
00190776433796Millennium1-6570502026-10-08
00190776433802Millennium1-6570512026-10-08
00190776433819Millennium1-6570532026-10-08
00190776399221Millennium1-1124282025-05-29
00190776433000Millennium1-161962026-10-26
00190776437060Millennium1-121219-122026-10-26
00190776437077Millennium1-410324C2026-10-26
00190776437084Millennium1-516410-6752026-10-26
00190776437091Millennium1-516420-6752026-10-26
00190776437107Millennium1-516430-6752026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421762MillenniumAvalign Technologies, Inc.HWI2026-06-24
08806373886355BENCOXCorentec Co., LtdHWI2026-06-09
08800017271088BENCOXCorentec Co., LtdHWI2026-05-06
00190776418878MillenniumAvalign Technologies, Inc.HWI2026-04-13
00190776416683MillenniumAvalign Technologies, Inc.HWI2026-02-16
00190776402471MillenniumAvalign Technologies, Inc.HWI2025-06-23
00810123207916Adler Instrument CompanyAdler, Inc.HWI2024-10-18
00841036284923N/ABIOMET MICROFIXATION, INCHWI2024-09-25
00822409100798N/AOrtho Development CorporationHWI2023-10-06
00190776292799MILLENNIUMAvalign Technologies, Inc.HWI2023-09-28
07898506815272QuinelatoSchobell Industrial LtdaHWI2023-07-06
14026704810991PILLINGTELEFLEX INCORPORATEDHWI2022-12-08
54026704810999PILLINGTELEFLEX INCORPORATEDHWI2022-12-08
00643169092020n/aMEDTRONIC SOFAMOR DANEK, INC.HWI2022-11-21
00842331156663Novo Surgical Inc. NOVO SURGICAL, INC.HWI2022-11-12
00673978058436Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWI2022-10-14
00673978129471Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWI2022-10-08
00673978131016Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWI2022-10-08
00190776183028MillenniumAvalign Technologies, Inc.HWI2021-11-01
00190776183035MillenniumAvalign Technologies, Inc.HWI2021-11-01
00190776183042MillenniumAvalign Technologies, Inc.HWI2021-11-01
00887868482854Cinch Modular AttachmentsBiomet Orthopedics, LLCHWI2021-03-24
00190660082734Ambler SurgicalAMBLER SURGICAL CORP.HWI2021-01-04
00889024595491Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595507Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595514Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595521Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595538Microfracture AwlZimmer, Inc.HWI2020-10-26
00889024595545Microfracture AwlZimmer, Inc.HWI2020-10-26
00841036284985N/ABIOMET MICROFIXATION, INCHWI2020-06-30